Otc - Purpose
Purpose
Methyl salicylate 10% Counterirritant
Camphor 5% Counterirritant
Capsaicin 0.025% Counterirritant
The following Structured Product Label (SPL) was submitted to the FDA by Guchutang Biotechnology (longyan) Co.,ltd. for the product Zkbb Arthritis Pain Relief (NDC 87083-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Purpose
Methyl salicylate 10% Counterirritant
Camphor 5% Counterirritant
Capsaicin 0.025% Counterirritant
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:
arthritis
simple backache
strains
bruises
sprains
Temporarily relieves muscle soreness and stiffness of joints.
Warnings
For external use only.
Do not use:
on wounds or damaged skin
with a heating pad or device
with other ointments, creams, sprays, or liniments
if you are allergic to any ingredients of this product
Ask a doctor before use if you have redness or irritated skin.
When using this product:
avoid contact with eyes and mucous membranes
do not bandage tightly or use with a heating pad
capsaicin may cause a burning sensation; wash hands after applying, except when treating the hands
Stop use and ask a doctor if:
the condition worsens or symptoms persist for more than 7 days
excessive skin irritation, burning, or redness occurs
If pregnant or breast-feeding, ask a health professional before use.
Directions
Adults and children 12 years of age and older: rub a thin film over the affected area not more than 3 to 4 times daily; massage is not necessary.
Children under 12 years of age: consult a physician.
Wash hands after use with cool water, except when treating the hands.
Avoid contact with eyes and mucous membranes.
Inactive ingredients
PEG-120 stearate, glyceryl monostearate, cetostearyl alcohol, water, phenoxyethanol, edetate calcium disodium, allantoin, sodium hydroxide, carbomer 940, dimethicone.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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